Specialist Instrument Qualification and Software Validation

Organization: 
Bayer
Job Location: 
Berkeley, CA
Job Description: 

Bayer HealthCare (BHC), an Equal Opportunity Employer, makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women's Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world's leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear.
Bayer’s corporate culture is an important factor in the company’s success. Central to this culture are our values: Leadership, Integrity, Flexibility and Efficiency, summarized by the term LIFE. They provide us with guidance for our daily work as we seek solutions to the major challenges of our time, in line with our mission statement “Bayer: Science For A Better Life".

Job description
Perform analytical computerized instrument and software validation, validation periodic review, and risk assessments to support variety of the labs within QC
organization. Prepare IOQ and other life cycle documents with high quality and accuracy.
Major Tasks:
• Computer and software validation, validation periodic review, and validation status list management. Writing validation protocols and final reports and function as a validation SME.
• Must be able to demonstrate knowledge of validation principles including user requirements, system specifications, IQ, OQ, and PQ

Requirements:
Your qualifications
Minimum Education:
Bachelor’s Degree in science
Minimum Experience:
6-8 years of experience in pharmaceutical or related industry or an equivalent combination of education and experience. 4+ years experience in performing analytical computerized instrument qualification and software validation
Special Skill/Knowledge:
• Strong understanding of cGMP, 21 CFR Part 11, global regulatory compliance
• Good technical/business writing and communication skills
• Knowledge in risk assessment, gap analysis, changes control and deviation management.
• Strong computer experience including words, excel, and databases.
• Strong understanding of Empower in administrator level.
•Excellent organizational skills, capable of multi-tasking and creating validation/qualification documents for multiple projects simultaneously.

Your application
We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards
and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our
employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.
If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.